Clinical trial · Interventional
Pharmacogenomics ANDA SNP Clinical Study - Topotecan and Single Nucleotide Polymorphisms
Explore the Relationship Between Single Nucleotide Polymorphisms and Topotecan Response and Toxicity in Patients With Small Cell Lung Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Explore the relationship between drug target topoisomerase I gene single nucleotide polymorphisms and Topotecan therapeutic-effects in patients with small cell lung cancer, based on Oxford precisely sequencing drug targets' genes. Explore the relationship between drug target CYP4503A4 gene single nucleotide polymorphisms and Topotecan side-effects in patients with small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| SCLC | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Topotecan - study | Drug | — | UNRESOLVED |
| Topotecan - usual | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Topotecan - usual
- description
- * Topotecan Capsule * Chemotherapy * Topotecan Capsule * Usual Approach Group
- interventionNames
- Drug: Topotecan - usual
- type
- EXPERIMENTAL
- label
- Topotecan - study
- description
- * China Import Topotecan Capsule * Chemotherapy * China Import Topotecan Capsule * Study Approach Group
- interventionNames
- Drug: Topotecan - study
Primary outcomes (1)
- measure
- Find Topotecan Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 24 Years
- Maximum age
- 64 Years
Show eligibility criteria text
* Select 600 Small Cell Lung Cancer Patients who are suitable for lung tissue biopsy * Dosage Duration at least 45 days * The usual approach group - Recruit 300 double blind random group separated SCLC patients currently used the Chemotherapy on Topotecan Capsule after lung tissue biopsy, like as the usual approach group. * The study approach group - Recruit 300 double blind random group separated SCLC patients currently used the Chemotherapy on China Import Topotecan Capsule after lung tissue biopsy, like as the study approach group. Inclusion Criteria: * 1\. Clinical diagnosis of Small Cell Lung Cancer (SCLC) * 2\. Clinical lung tissue biopsy diagnosis of SCLC * 3\. Suitable for enough lung tissue biopsy of SCLC * 4\. Random and double blind * 5\. Measurable disease * 6\. Adequate organ functions * 7\. Adequate performance status * 8\. Age 24 years old and over * 9\. Sign an informed consent form * 10\. Receive blood-drawing Exclusion Criteria: * 1\. Pneumonectomy * 2\. Treatment with other anti-cancer therapies and cannot be stopped currently * 3\. Pregnancy * 4\. Breast-feeding * 5\. The patients with other serious intercurrent illness or infectious diseases * 6\. Have more than one different kind of cancer at the same time * 7\. Serious Allergy to Drugs * 8\. Clot or Bleed Tendency * 9\. Serious Risks or Serious Adverse Events of the drug product * 10\. The prohibition of drug products * 11\. Have no therapeutic effects * 12\. Follow up to the most current label
References
Publications (0)
Data not yet available